Vyome (HIND) investor relations material

Development strategy

• Focuses on high-unmet-need indications with no FDA-approved therapy, using capital-efficient clinical development and a simple common-stock capital structure.

• Drug discovery approach repositions existing drugs around unmet clinical needs and their mechanisms, informed by known risks.

• Q2 operating expenses were $874,000, supported by lean operations, Indian scientific and cost advantages, backend support, and specialist consultants.

VT-1953 safety and clinical signal

• The topical 2% gel completed five clinical studies, including chronic dosing up to 90 days; it has been tested in over 400 patients with a reported clean safety profile.

• Investigator-initiated Phase II enrolled 15 patients, with 10 receiving drug and 5 vehicle, dosed twice daily for 14 days.

• The pilot showed significant odor reduction versus placebo (P=0.01), along with significant pain reduction and improvement in patient-reported psychological outcomes.

• No improvement was seen with placebo, and some placebo patients worsened.

Disease and mechanism

• Malignant fungating wounds occur in about 10% of advanced cancer patients, often with breast or head and neck cancer; symptoms include severe odor, exudate, infection, and psychological distress.

• VT-1953 is described as having broad antibacterial activity and inhibiting toll-like receptor signaling, targeting both bacterial burden and inflammation associated with pain and exudates.

• Off-label metronidazole addresses anaerobic bacteria, while the discussion characterized it as missing more than 50% of the causes of symptoms in these wounds.